Zafirlukast (Page 6 of 6)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

10 mg Container label

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20 mg container label

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ZAFIRLUKAST
zafirlukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-625
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zafirlukast (Zafirlukast) Zafirlukast 10 mg
Inactive Ingredients
Ingredient Name Strength
hydroxypropyl cellulose
HYPROMELLOSE 2910 (5 MPA.S)
lactose monohydrate
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code R;625
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-625-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:55111-625-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:55111-625-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:55111-625-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:55111-625-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-625-79)
5 NDC:55111-625-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (55111-625-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090372 11/18/2010
ZAFIRLUKAST
zafirlukast tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-626
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zafirlukast (Zafirlukast) Zafirlukast 20 mg
Inactive Ingredients
Ingredient Name Strength
hydroxypropyl cellulose
HYPROMELLOSE 2910 (5 MPA.S)
lactose monohydrate
magnesium stearate
CELLULOSE, MICROCRYSTALLINE
polyethylene glycol 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code R;626
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-626-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:55111-626-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:55111-626-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:55111-626-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:55111-626-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-626-79)
5 NDC:55111-626-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (55111-626-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090372 11/18/2010
Labeler — Dr. Reddys Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited(FTOIII) 918608162 manufacture (55111-625), analysis (55111-625), manufacture (55111-626), analysis (55111-626)

Revised: 11/2018 Dr. Reddys Laboratories Limited

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